Sr Principal, Patient Safety & Experience

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Sr. Principal, Patient Safety & Experience you serve as the medical and scientific safety leader for assigned Alcon projects or products. You will be trusted to work on the integration, analysis, and interpretation of safety information from clinical development through post-approval lifecycle. In this role, located in Fort Worth, Texas, a typical day will include:

• Providing safety surveillance throughout a product's lifecycle through safety trending, signal detection, and risk management assessments.
• Provide safety support to the clinical development team in clinical trials and post marketing programs through identifying, monitoring, and evaluating safety parameter.
• Participating in the resolution of any questions from regulatory agencies and other mitigation activities addressing legal, safety, and compliance risks.
• Performing medical review of single cases and or aggregate data involving assigned products.
• Providing medical input into HHAs and responses to reg authorities, HCPs, local affiliates, and Legal on Safety issues.
• Providing safety input into clinical and regulatory results including Investigator Brochures, study protocols study reports, clinical overviews, CERs, product registrations.
• Supervising the clinical safety of assigned products/projects, including adverse events, and patient impact from tech complaints from studies, literature, and post-market surveillance.
• Authoring or providing safety input into the preparation and maintenance of PMSP, periodic safety updates, product labeling and related documents.
• Leading cross functional projects, provide guidance on safety topic and collaborate with R&D and business partners.
• Providing guidance on event coding, causality assessment and determination of anticipated vs unanticipated AE reports.
• Identifying safety signals based on review of solicited or unsolicited cases. Perform signal triage activities, evaluation, and presentation to Alcon boards, including preparatory activities.
• Support BD&L activities, HA inspections/audits and project/product recalls.
• Collaborating with Franchise Director to develop safety strategy and implementation plan for new product launches.

• Bachelor's Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience

• OD, or MD/DO with Ophthalmology Specialty

• Benefit from working in a highly collaborative environment.
• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!
• Travel Requirements: 10%
• Relocation assistance: Yes
• Sponsorship available: No

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.